▷ Urgent Search: Director GMP Data Governance

1 day ago

Limerick, Ireland Regeneron Ireland DAC Full time

In this role you will act as a bridge between global policy and standard setting and the local implementation of these within the site business unit(s). Your role will play a fundamental part in safeguarding the quality and reliability of the organisation's data which is essential for informed decision making and regulatory compliance. In this role, a typical day might include the following: Successful building, leading and managing of the site Data Operations & Engagement, Culture & Monitoring (ECM) team Successful delivery/implementation of site data governance (DG) responsibilities and standards Responsible for successful stakeholder engagement and management across the site Responsible for establishing a successful relationship with the global Governance Team (Policies & Programs) so a clear feedback loop is established Responsible for the creation and delivery of DG training programs in consultation with Global Data Governance Senior Leadership Team Ensuring the team is appropriately resourced, supported and has the tools and direction to properly execute their function Leading cultural and people change management efforts related to DG ensuring smooth adoption of new processes, systems and ways of working within the relevant site Responsible with and through the ECM Specialists for developing and embedding DG culture across all elements of IOPS site work Responsible with and through DG Business Partners for the successful delivery of global standards, policies and procedures at site level and the monitoring of adherence to these standards Fostering a culture of quality and DG within the organisation and promoting the importance of DG across all departments Driving communication and collaboration between stakeholders to ensure effective DG practices Leading/supporting initiatives to embed DG principles into the company's core values and everyday practices This role may be for you if you have: Technical knowledge within the biotech or pharmaceutical sector, coupled with strong relationship building and analytical thinking skills Experience in implementing DG policies and initiatives within business units in a regulated environment Experience in cultural/people change management and driving cultural change related to DG Knowledge of applicable federal, state, and local regulations (e.g. GDPR), rules, policies, and procedures such as FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to Data Integrity Strong understanding of data governance principles, regulatory requirements and industry standards and the practical application of these in business operations Extensive experience demonstrating ability to partner, influence and incorporate new standards Strong people management and team leadership experience Experience of managing and implementing training programs and monitoring KPI achievement Strong stakeholder management and influencing skills The ability to adapt in the face of changing business needs To be considered for this role you must hold a BA/BS degree and 12+years of professional experience or equivalent combination of education and experience in one of the following pharmaceutical/FDA regulated work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT. Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

  • Director GMP Data Governance

    1 day ago

    Limerick, Ireland Regeneron Ireland DAC Full time

    Your role is fundamental in ensuring Regeneron's data is effectively managed and utilised whilst remaining compliant with regulatory requirements. You will play a key role in fostering a data compliance culture and being accountable for developing comprehensive Data Governance (DG) policies and procedures across the organization. You will monitor the...

  • Principal GMP Data Governance Specialist

    1 day ago

    Limerick, Ireland Regeneron Ireland DAC Full time

    The Principal GMP Data Governance Specialist plays a pivotal part in ensuring that Regeneron's Data Governance (DG) systems and practices meet the highest standards of regulatory and industry compliance. You will beresponsible for providing specialised knowledge and expertise in the design of (DG) frameworks, policies and procedures that are aligned with...

  • (High Salary) Executive Director GMP Data Governance

    1 day ago

    Limerick, Ireland Regeneron Ireland DAC Full time

    This leadership role is fundamental in creating, building & motivating a global Data Governance (DG) team responsible for maintaining compliance with regulatory standards. It offers an opportunity to shape the DG landscape of Regeneron, driving innovation and excellence through data. The role will suit a visionary leader with a passion for data and a track...

  • Principal GMP Data Governance Business Partner

    1 day ago

    Limerick, Ireland Regeneron Ireland DAC Full time

    In this role you will be responsible for the implementation of data governance (DG) standards, policies and procedures into business operations. You will be a site resource and subject matter expert on good DG practices and ensure Business Groups are aligned to the IOPS Data Governance Program. Your remit will involve supporting the Regeneron Industrial...

  • Sr GMP Data Governance

    1 day ago

    Limerick, Ireland Regeneron Ireland DAC Full time

    In this role you will be responsible for fostering a culture of data governance (DG) within the site by ensuring compliance with Data Governance policies; designing and delivering relevant training; and monitoring Data Governance practices. The role is pivotal in promoting data stewardship, enhancing data quality and ensuring the principles are embedded in...

  • Urgent Search: Data Modeler

    8 hours ago

    Limerick, Ireland SOLAS IT RECRUITMENT Full time

    Data Modeler – SQL **Must Be in Ireland** We are looking for aData Modelerto join our team. The ideal candidate will have a strong background in data modelling, preferably usingErwinorArchimatetools, and experience withOrbus iServeris highly desirable. The role will involve creating, managing, and optimizing conceptual, logical, and physical data models,...

  • ▷ Urgent Search: Director of Operations

    1 day ago

    Limerick, Ireland Nexus Recruitment Partners Full time

    Job Title: Chief Operations Director (COD) Location: Limerick Reports To: Business Owner Industry: Construction Employment Type: Full-Time MUST HAVE EXPERIENCE IN THE IRISH CONSTRUCTION SECTOR I AM CURRENTLY SHORTLISTING CANDIDATES AND WILL ONLY REPLY IF SUITABLE About Us: My client is a leading provider of exterior building systems, specializing in both...

  • Quality Assurance Associate

    4 hours ago

    Limerick, Ireland FRS Recruitment Full time

    Perfect QA role for a self-starter with a strong background in Quality Assurance and GMP In this key QA position, you'll take ownership of Quality Assurance activities to ensure biological products are manufactured in strict compliance with GMP and regulatory standards. You'll collaborate across departments, manage critical QMS responsibilities, and...

  • ▷ Urgent Search: Reliability Engineer

    14 hours ago

    Limerick, Ireland Life Science Recruitment Full time

    Reliability Engineer We’re currently recruiting for an exciting opportunity with a Pharmaceutical organisation based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are addressing some of the world’s most challenging healthcare needs. Reporting to the API Reliability & Systems Lead, this role...

  • Director of Software Development

    2 days ago

    Limerick, Ireland IT Search Full time

    Director of Software Development opportunity with Limerick based SaaS project house. This person will manage the key strategic direction and leadership for a significant Development team. This is a hybrid working role (1-2 days in Limerick) and salary guide is 120-130K + 15% bonus + benefits Responsibilities Strategic leadership for c100 Developers across 5...

  • ▷ [Only 24h Left] Principal Data Engineer

    8 hours ago

    Limerick, Ireland 1020 ADBV Ireland Full time

    Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably...

  • ▷ (Urgent Search) Maintenance & Reliability - Principal Instrumentation Engineer

    14 hours ago

    Limerick, Ireland Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • ▷ Urgent: Instrument Specialist

    1 day ago

    Limerick, Ireland PSC Biotech Full time

    Tipperary, Ireland | Posted on 12/02/2024 - Industry: Pharma/Biotech/Clinical Research - Work Experience: 1-3 years - Country: Ireland Job Description About PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US,...

  • ▷ [Urgent Search] Assistant Project Manager for MCAAS-2 Region West

    14 hours ago

    Limerick, Ireland Roughan & O'donovan Full time

    Roughan & O’Donovan (ROD) is looking to recruit an Assistant Project Manager for the Motorway Contracts, Audit and Administration Services (MCAAS-2) Contract. Job type: Contract Duration: Up to three years About the role You will be part of a team with responsibility for monitoring and supervising the contractors involved in motorway maintenance and...

  • Master Data Management Architect

    1 day ago

    Limerick, Ireland SOLAS IT RECRUITMENT Full time

    Master Data Management (MDM) Architect -**Must be in Ireland** We are seeking an experienced Master Data Management (MDM) Architect to drive the strategic evolution of our Oracle Fusion Platform applications. This role will focus on the ongoing development and optimization of our existingCustomer Data Management (CDM)andProduct Data Hub (PDH)systems,...

  • (Urgent) DeltaV Automation Engineer 1520

    22 hours ago

    Limerick, Ireland SimoTech Full time

    Specialists in Life Science Automation and IT Systems Stay Connected: SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational...

  • Research Associates

    14 hours ago

    Limerick, Ireland Glass, Lewis & Co. Full time

    Company Overview Glass Lewis is the world’s choice for governance solutions. We enable institutional investors and publicly-listed companies to make sustainable decisions based in research and data. We cover 30,000+ meetings each year, across approximately 100 global markets. Our customers include the majority of the world’s largest pension plans,...

  • [Urgent Search] Accountant

    1 day ago

    Limerick, Ireland FDC Group Full time

    Are you ready for a change? Become part of F.D.C. and Associates Ltd, as part of FDC Group. FDC Group is a fast growing, full service, multi-disciplined professional services provider. Established in 1973, with headquarters in Cork and 40+ office locations nationwide, we offer a range of Accounting, Auditing, Taxation, Agri-Consultancy, Financial and...

  • Customer Support and Tender Representative with Hungarian

    1 week ago

    Limerick, Ireland Cook Ireland Ltd Full time

    Overview The Customer Support and Tender Representative 1 is responsible for providing a professional, friendly and efficient service to Cook Medical Customers, Sales Teams and / or Distribution Partners (DPs) throughout the world covering all aspects of support including Customer Service, Tender Coordination and Finance Administration as required -...

  • ▷ Immediate Start: Consultant Geriatrician

    15 hours ago

    Limerick, Ireland OASIS Group Full time

    Six Health Regions have been established within the HSE, based on the geographical boundaries agreed by the Government in July 2019, and they will be fully operational from 2024. Each Health Region will be tasked with population-specific planning, resourcing, and delivery of health and social care services for the needs of its unique population. This will...